ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12612000585820

Ethics application status

Not yet submitted

Date submitted

29/05/2012

Date registered

30/05/2012

Date last updated

30/05/2012

Type of registration

Prospectively registered

Titles & IDs

Public title

Treatment of irritable bowel syndrome: Using dietary carbohydrate restriction and hypnotherapy as complementary therapies

Scientific title

Treatment of irritable bowel syndrome: Using dietary carbohydrate restriction and hypnotherapy as complementary therapies

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Irritable bowel syndrome

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants are randomised to receive one of three treatment conditions:
1. Hypnotherapy
Hypnotherapy sessions are one hour in duration and will occur weekly for a total of six weeks. Hypnotherapy sessions will be delivered by a registered clinical hypnotherapist, Ms Simone Peters who has specific training and knowledge in using hypnotherapy for the treatment of IBS. Each participant will receive the same information in each of the hypnotherapy sessions. Participants will also be required to listen to a daily hypnosis audiotape. This audiotape will be a recording of the first hypnosis session.

2. Low FODMAP (fermentable, oligosaccharides, disaccharides, monosaccharides and polyols) dietary intervention
The low FODMAP dietary intervention will consist of a one hour initial dietary consultation in week one and a review consultation in week six. The low FODMAP diet will be taught by a practicing dietitian, Dr Sue Shepherd who has specific training and knowledge in using the low FODMAP diet for the treatment of IBS. Each participant will receive the same information in the initial and follow up dietary consultations.

3. Combination of both hypnotherapy and low FODMAP diet
The combination treatment condition will include one hour, weekly hypnotherapy sessions for six weeks; one hour initial dietary consultation in week one and review consultation in week six. The hypnotherapy and low FODMAP interventions will be given simultaneously.

Each participant receives the same information in each of the hypnotherapy sessions becuase the sessions are scripted. Therefore, once the participant has entered a state of hypnosis they are essentially read the same 'script' as every other participant in the hypnotherapy condition.

Participants in the low FODMAP treatment condition will be provided with information about the low FODMAP diet i.e. what the low FODMAP diet is, what foods are 'safe' on the low FODMAP diet etc
Participants are then required to utilise the diet themselves. The dietitan, Dr Sue Shepherd will have weekly telephone contact with participants to ensure compliance.

Intervention code [1]

Treatment: Other

Intervention code [2]

Lifestyle

Comparator / control treatment

Participants are randomised to one of three treatment conditions: hypnotherapy, low FODMAP diet and combination (both hypnotherapy and low FODMAP diet). Before participants are randomised to one of these three treatments they are asked to complete an irritable bowel syndrome gastrointestinal symptom questionnaire which records the amount and severity of gastrointestinal symptoms they are currently experiencing. They are also asked to complete various psychological measures (Hospital Anxiety and Depression Scale - HADS, State-Trait Personality Inventory - STPI, Irritable bowel syndrome - Quality of Life - IBS-QOL). Once these measures have been completed they will be randomised to one of the treatments.

Participants are then asked to complete these same questionnaires at the completion of the treatment condition (either the hypnotherapy, low FODMAP or combined treatment - depending on which treatment they were randomised to).

Therefore, while there is not a control condition as such (i.e. placebo) each participant acts as their own control in that responses to questionnaires following treatment are considered in relation to responses to questionnaires before the commencement of treatment.

Control group

Active

Outcomes

Primary outcome [1]

The change in overall gastrointestinal symptom scores (as measured using a 10cm visual analogue scale) on completion of each of the treatment conditions

Timepoint [1]

At completion of each treatment condition (2 weeks) and then at 3 and 6 months follow-up

Secondary outcome [1]

Assessment of psychological status in pateints on completion of each of the treatment conditions. Psychological status is measued using validaded psychological questionnaires including; HADS, STPI, IBS-QOL (see previous page for questionnaire full names)

Timepoint [1]

At completion of each treatmet condition (2 weeks) and then at 3 and 6 months follow-up

Eligibility

Key inclusion criteria

18 years old, met Rome III criteria for IBS, coealic disease excluded by normal duodenal biopsy or HLA DQ2 (human leukocyte antigen) and HLA DQ8 (human leukocyte antigen) negative

Minimum age

18 Years

Maximum age

75 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Marsh 1 or 2 lesions, other significant gastrointestinal disease (e.g. cirrhosis, inflammatory bowel disease), other clinically significant co-morbidity, psychiatric disease, pregnancy, alcoholism

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Particicipants who meet eligibility criteria will be enrolled in the study. Eligible participants will be randomised to one of three treatment conditions:
1. Hypnotherapy
2. Low FODMAP diet
3. Combination (Hypnotherapy & Low FODMAP diet)
Allocation concealment will be performed - participants will be assigned to one of the three treatment conditions by a centrally randomised computer generated list.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Allocation concealment will be performed - participants will be assigned to one of the three treatment conditions by a centrally randomised computer generated list.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/07/2012

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

Monash University

Address [1]

Department of Gastroenterology
Block B, Level 6
The Alfred Centre
99 Commercial Road
Prahran VIC 3181

Country [1]

Australia

Primary sponsor type

University

Name

Monash University

Address

Department of Gastroenterology
Block B, Level 6
The Alfred Centre
99 Commercial Road
Prahran VIC 3181

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

The Alfred Research and Ethics Unit

Ethics committee address [1]

Third Floor, East Block
The Alfred Hospital
Commercial Road
Melbourne VIC 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/05/2012

Approval date [1]

Ethics approval number [1]

1/12/0197

Summary

Brief summary

Irritable bowel syndrome (IBS) is a chronic functional gastrointestinal disorder. Current treatment strategies of IBS are unsatisfactory. Currently there are three common modes of treatment for IBS including: drugs, diet and psychological therapies. 

Pharmacologic interventions are generally not effective in treating IBS and no drug has been shown to relieve the full spectrum of gastrointestinal symptoms that make up IBS.

Two common modes of treatment, however, that have been scientifically proven to relieve the symptoms of IBS include hypnotherapy and the low FODMAP diet.

Gut-focused hypnotherapy uses hypnosis to induce a deep state of relaxation allowing the subconscious mind to become highly receptive to suggestions directed towards the control and normalisation of gut function.
Recently published scientific research has shown that gut-focused hypnotherapy can have a 70+% success rate in the reduction of abdominal symptoms including abdominal pain, bloating, constipation and diarrhoea. Additionally, gut-focused hypnotherapy has been shown to improve overall well-being and quality of life, reduce anxiety and depression and reduce medication needs. Furthermore, these improvements have been shown to be maintained for 2-5 years. 

FODMAPs (Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols) are a group of dietary sugars that can be poorly absorbed in people with IBS. When these sugars are poorly absorbed in the small intestine they continue along the gastrointestinal tract and arrive at the large intestine where they act as a food source to the bacteria that normally live there. The bacteria of the large intestine then ferment these FODMAPs and can cause symptoms of IBS. 
Recently published scientific research has shown that dietary restriction of these poorly absorbed FODMAP sugars (the low FODMAP diet) can have a 75% success rate in the reduction of abdominal symptoms including abdominal pain, bloating, constipation and diarrhoea. Additionally, the low FODMAP diet has been shown to improve levels of fatigue amongst this population. 

While both the low FODMAP diet and hypnotherapy significantly reduce symptoms in the majority of IBS patients, the benefit of combining these therapies has not yet been investigated.  It is anticipated that this study will shed light on the benefit of applying these therapies both individually and in combination with one another, allowing GPs and gastroenterologists to direct IBS patients to the best available treatment which may be tailored to each individual patient. 

Aims
To assess the effectiveness of using dietary carbohydrate restriction (the low FODMAP diet) and hypnotherapy as complimentary therapies for the effective management of IBS

To compare the combined treatment of the low FODMAP diet and hypnotherapy to each of the standalone therapies

To assess the long term effectiveness of each of the treatment conditions
 
Hypotheses
Hypnotherapy will improve IBS symptom severity and psychological status amongst the IBS population

The low FODMAP diet will improve IBS symptom severity and psychological status amongst the IBS population

Hypnosis and the low FODMAP diet as complimentary therapies will improve IBS symptom severity and psychological status to a greater extent than if these two therapeutic modalities were administered independently

Improvements in IBS symptom severity and psychological status will be maintained at 3 and 6 months following each of the treatment conditions

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Ms Simone Peters

Address

Department of Gastroenterology
Block B, Level 6
The Alfred Centre
99 Commercial Road
Prahran VIC 3181

Country

Australia

Phone

+61 3 9903 0262

Fax

+61 3 9903 0556

simone.peters@monash.edu

Contact person for scientific queries

Name

Ms Simone Peters

Address

Department of Gastroenterology
Block B, Level 6
The Alfred Centre
99 Commercial Road
Prahran VIC 3181

Country

Australia

Phone

+61 3 9903 0262

Fax

+61 3 9903 0556

simone.peters@monash.edu

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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Documents added automatically

No additional documents have been identified.

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